EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes

Background of the EN ISO 15189:2022 revision

The EN ISO 15189:2022, titled “Medical laboratories – Requirements for quality and competence,” represents a significant update to the standards governing medical laboratories [1]. This document was developed by the Technical Committee ISO/TC 212, which focuses on clinical laboratory testing and in vitro diagnostic test systems, in partnership with the European Committee for Standardization (CEN), specifically the CEN/TC 140 that addresses in vitro diagnostic medical devices. The updated standard was approved and published on December 6, 2022, effectively replacing both EN ISO 15189:2012 [2] and EN ISO 22870:2016 [3]. The latter was dedicated to point-of-care testing (POCT).

Objectives of the ISO/TC 212 WG drafting team

The revision was driven by several key objectives established by the drafting team:

1. Alignment with ISO/IEC 17025:2017 [4]:

   1. The revised EN ISO 15189:2022 was updated to ensure consistency and coherence with the revisions made to ISO/IEC 17025:2017 which pertains to testing and calibration laboratories.

2. Removal of unintended prescription:

   1. The team aimed to eliminate any unintended prescriptive elements from the previous version that may have caused confusion or misinterpretation, thus providing greater flexibility in implementation.

3. Focus on patient interest and safety:

   1. The revised document introduces the concept of “risk-based thinking”, emphasizing the importance of patient welfare in laboratory decision-making processes.

   2. It clarifies the difference between risk assessment (quantifying risk by considering both the opportunity and the potential impact) and risk management (implementing strategies to address identified risks).

4. Minimization of new requirements:

   1. The drafting team sought to limit the introduction of new requirements to avoid overwhelming laboratories while still addressing critical areas for quality and competence.

5. Improved clarity of text:

   1. The team focused on refining the language and structure of the standard to improve its interpretability and applicability, with the goal of providing for clearer guidance for laboratories.

The ISO/TC 212 drafting team acknowledged several concerns raised during the review process:

1. Perception of new requirements:

   1. Some stakeholders, particularly from National Accreditation Bodies (NABs), perceived that any differences in text would signal new requirements, suggesting intentions which were no objective of the drafting team. The intent was to clarify existing requirements rather than introduce new ones, addressing previous misconceptions and unintentional prescriptions.

2. Risk-based thinking misinterpretation:

   1. There was concern that references to risk-based thinking could be misread as necessitating specific risk assessment protocols. The true aim is to facilitate decision-making in the patient’s best interest rather than impose mathematical calculations.

   2. The standard provides practical examples to illustrate risk-based thinking. For instance, when handling a compromised clinically critical or irreplaceable sample, the focus should be on the patient’s safety. Accepting such a sample may depend on its potential value vs. the availability of a better sample. This illustrates the principle of making informed, patient-centred decisions based on risk assessment rather than rigid adherence to predefined criteria.

Objectives of the EFLM Committee on Accreditation and ISO/CEN standards in terms of EN ISO 15189:2022 revision

According to the terms of reference for the Committee on Accreditation and ISO/CEN standards, the Committee (C: A/ISO) is dedicated to harmonizing accreditation processes across Europe. The C: A/ISO produces comprehensive guidance documents aimed at assisting laboratories in understanding and implementing accreditation standards. These documents are designed to facilitate the translation of complex standards into practical applications for laboratory settings and help educate specialists in laboratory medicine and assessors from accrediting bodies on the application of specific professional standards outlined in EN ISO 15189:2022, ensuring that all stakeholders are equipped with the knowledge to adhere to the standards effectively.

In May 2023, the C: A/ISO agreed on two main objectives to enhance the understanding and implementation of the revised standard:

1. Clarification of relevant changes:

   1. The C: A/ISO committed to explaining and clarifying the most significant changes introduced in the EN ISO 15189:2022 revision. By doing so, they aim to promote effective implementation of the new requirements within medical laboratories.

2. Impact analysis on previous C: A/ISO guidance documents:

   1. The C: A/ISO also recognized the need to analyse how the recent revisions affect previous guidance documents. This analysis helps ensure that the updated standards are appropriately reflected in existing practices and guidance.

This document has been prepared with a specific target audience in mind:

1. Medical laboratory professionals:

   1. The guidance is aimed at laboratory staff who need to understand the revised (formulations of the) requirements and how to apply them effectively in their day-to-day operations.

2. NABs:

   1. The document provides insights for assessors of accreditation bodies, helping them to align their assessment processes with the updated standard.

3. Stakeholders in medical laboratory testing:

   1. It serves as a resource ensuring that they are informed about the changes and their implications for laboratory practices.

General remarks on changes from EN ISO 15189:2012 to EN ISO 15189:2022

The members of the C: A/ISO have reached a consensus on several important changes and emphases in the transition from EN ISO 15189:2012 to EN ISO 15189:2022. These remarks outline the key modifications and the reasoning behind them:

1. Alignment with ISO/IEC 17025:2017:

   1. The structure of EN ISO 15189:2022 has been aligned with the revised ISO/IEC 17025:2017 to enhance coherence and consistency across laboratory standards.

2. Inclusion of support of POCT as previously described in the now withdrawn EN ISO 22870:2016:

   1. The inclusion of POCT in the standard is supported by the reasoning that POCT plays a crucial role in delivering timely patient care, necessitating clear guidelines and standards for its implementation. Previously EN ISO 22870:2016 formulated requirements for EN ISO 15189:2012 accredited medical laboratories on how to support POCT operated by staff outside the responsibility of their laboratory staff. The inclusion of those requirements in the current EN ISO 15189:2022 has led to the withdrawal of the now obsolete EN ISO 22870:2016. Guidance for operators of POCT is still available in ISO/TS 22583:2024, entitled Requirements and recommendations for supervisors and operators of POCT equipment [5]. That document refers such user to EN ISO 15189:2022 accredited medical laboratory for adequate support of POCT implementation and use.

3. Surveillance and revision of terms and definitions:

   1. The revision emphasizes the need for continuous surveillance and periodic revision of terms and definitions to ensure clarity and relevance in the evolving landscape of medical laboratory practices.

4. Autonomy in implementation:

   1. Laboratories are allowed more autonomy in the implementation of the standard, empowering them to tailor processes according to specific needs of their population served, while still adhering to overarching quality requirements.

5. New perspectives in key clauses:

   1. The revision introduces fresh perspectives in various clauses:

      1. Clause 4.1 (Impartiality) emphasizes the importance of unbiased practices.

      2. Clause 7.7 (Complaints) focuses on effective handling and resolution of complaints.

      3. Clause 7.8 (Continuity and emergency preparedness planning) addresses the necessity for contingency plans and continuity of services.

      4. Clause 8.5 (Risk management and opportunities for improvement) stresses the importance of proactive identification and management of risks, as well as fostering opportunities for continuous improvement.

      5. The reporting of results has been simplified to improve clarity and usability (Section 7.4.1).

6. Strategic and risk-based approach:

   1. There is an increased emphasis on adopting a strategic and risk-based approach to laboratory management, ensuring that patient safety and interests are at the forefront of decision-making processes.

7. Patient-centric orientation:

   1. The revision improves orientation towards patient interests, highlighting the necessity of prioritizing patient care in laboratory operations.

8. Clarification of requirements:

   1. The revision makes clear distinctions between “shalls,” “shoulds,” and “coulds,” providing guidance on mandatory vs. recommended practices.

   2. New examples are included to illustrate concepts without introducing new requirements; rather, these are framed as clarified interpretations of existing standards.

   3. Only where considered necessary to prevent misconception the standard now contains some educational explanation. An example is the explanation of the impact of (the lack of) commutability in clause 7.3 (Examination processes) with regard to quality control.

9. Integration with related documents:

   1. EN ISO 15189:2022 is positioned as part of a suite of documents, with a focus on avoiding duplication of details covered in supporting standards, including:

      1. ISO 22367:2020 Medical laboratories – Application of risk management to medical laboratories [6].

      2. ISO 15190:2020 Medical laboratories – Requirements for safety [7].

      3. ISO 35001:2019 Biorisk management for laboratories and other related organizations [8].

      4. ISO/TS 20914:2019 Medical laboratories - Practical guide for measurement of uncertainty [9].

      5. ISO 20658:2023 Medical laboratories – Requirements for the collection and transport of samples for medical laboratory examinations [10].

Closing remarks

Whether a laboratory judges the changes in the standard as major or not, may also depend on the degree to which the particular laboratory already complied to the new standard before its publication. This is very well possible because laboratories base their procedures not solely on requirements in standards, but in the first place on what they deem right in the interest of their community served. This was already the intent of EN ISO 15189:2012. With this in mind the detailed analysis of changes as documented in Annex 1 should be read.

This document contains 2 annexes:

Annex 1 describes the C: A/ISO specific comments to the most important changes. Annex 2 describes the impact of the revision of the standard on the persisting validity of earlier published specific guidance on the standard by C: A/ISO.

Conclusions

The C: A/ISO is committed to fostering a unified approach to laboratory accreditation in Europe. Through the development of guidance documents and educational initiatives, it aims to support medical laboratories in successfully navigating the changes brought about by the EN ISO 15189:2022 revision, ultimately enhancing the quality and safety of laboratory services across the region.

The transition from EN ISO 15189:2012 to EN ISO 15189:2022 represents a significant evolution in the standards governing laboratory practices. The 2022 version emphasizes a more explicit and comprehensive approach to impartiality, confidentiality, patient care and patient interest in particular risk management, emergency planning, and documentation requirements. These enhancements aim to improve laboratory quality and patient safety, ensuring that laboratories not only meet regulatory requirements but also foster trust and transparency in their operations.